India has taken a significant step to protect public health by banning the use of Nimesulide above 100 mg. The Ministry of Health and Family Welfare has issued a strict prohibition on the manufacture, sale, and distribution of oral Nimesulide formulations containing more than 100 mg, citing potential liver damage risks. This decision comes after extensive safety concerns and the recognition of safer alternatives.
Nimesulide, a non-steroidal anti-inflammatory drug (NSAID), has been a common prescription for pain relief, inflammation, and fever in adults. However, it has been linked to liver damage, ranging from enzyme increases to severe liver failure, a condition known as hepatic risk. Unlike many NSAIDs, Nimesulide was never approved in the United States due to safety concerns and is also not approved in Canada, Japan, Australia, and several other countries. Some European nations initially allowed it with prescriptions but later restricted or banned it due to liver safety issues.
The Indian government's decision, announced on December 29, aims to safeguard public health and safety. The notification states that the government is satisfied that high-dose Nimesulide formulations pose a risk to humans and that safer alternatives are available. The ban is effective immediately and applies to all oral formulations containing Nimesulide above 100 mg in immediate-release dosage forms.
This move is based on recommendations from the Drugs Technical Advisory Board (DTAB) and is in exercise of powers conferred under Section 26A of the Drugs and Cosmetics Act, 1940. The Ministry had previously banned Nimesulide formulations for use in children below 12 years of age and prohibited its use in animals, citing safety concerns. While most large pharmaceutical companies had phased out higher-dose Nimesulide formulations, smaller manufacturers continued to market them, prompting a comprehensive ban to eliminate residual availability.
The ban is specific to oral, immediate-release Nimesulide formulations above 100 mg and does not amount to a blanket prohibition. Patients are advised to consult doctors for alternatives if needed and not to stop medication abruptly. This decision highlights India's commitment to public health and safety, ensuring that safer alternatives are available for managing pain and inflammation.
